This invention relates to medical suturing instruments and more particularly to drive means in such instruments for advancing a suture strand through tissue, and the like.
Suturing instruments are typically used to draw together two or more portions of a subject patient (e.g., tissue such as muscle or skin) or to attach an object to the patient (e.g., to attach a piece of surgical mesh to the abdominal wall of the patient during hernia repair surgery).
Certain suturing instruments employ a needle that precedes a length of suture material through a subject.
For example, U.S. Pat. Nos. 3,470,875; 4,027,608; 4,747,358; 5,308,353; 5,674,230; 5,690,653; 5,759,188; and 5,766,186 generally disclose suturing instruments in which a needle, with trailing suture material, is passed through a subject.
U.S. Pat. Nos. 4,890,615; 4,935,027; 5,417,700; and 5,728,112 generally disclose suturing instruments in which suture material is passed through the end of a hollow needle after that needle has passed through a subject.
With all of the foregoing devices, a needle must be passed through the subject in order to deploy the suture. This is generally undesirable, since the needle typically leaves a larger hole in the subject than is necessary to accommodate only the suture material. In this respect it should be appreciated that it is generally desirable to alter each portion of the material being sutured as little as possible.
A suturing instrument has been devised which permits the suture material itself to pierce the subject without the use of a needle. However, this device does not permit sufficient flexibility with regard to the amount of tension that may be applied to the suture and tissue.
More particularly, U.S. Pat. No. 5,499,990 discloses a suturing instrument in which a 0.25 mm stainless steel suturing wire is advanced to the distal end of a suturing instrument, whereupon the distal end of the suturing wire is caused to travel in a spiral direction so as to effect stitches joining together two portions of a subject. After the spiral is formed, the beginning and end portions of the suture may be bent toward the tissue in order to inhibit retraction of the suture wire into the tissue upon removal of the suturing instrument. The stainless steel wire is sufficiently firm to hold this locking set. In addition, after the spiral is formed, the radius of the deployed suture spiral may then be decreased by advancing an outer tube over a portion of the distal end of the instrument. Again, the stainless steel wire is sufficiently firm to hold this reducing set.
Unfortunately, however, such a system does not permit sufficient flexibility in all situations with regard to the appropriate amount of tension to be applied to the subject, since the wire is relatively firm (i.e., firm enough to hold its sets). Such a system also does not provide sufficient flexibility with regard to the appropriate type of suture stitch to be applied, since the device is specifically configured to provide only a spiral suture stitch.
In contrast to the aforementioned limitations of the suturing instrument of U.S. Pat. No. 5,499,990, it is desirable that a suturing instrument approximate the portions of the material which is to be joined in the correct physiological relationship, and to urge the portions together with an appropriate amount of force. If too much force (or tension) is applied to the suture material, then the subject portions may become necrotic or the sutures may cut through the subject. If too little tension is applied to the suture material, then the healing process may be impaired.
U.S. Pat. No. 4,453,661 discloses a surgical instrument for applying staples. The staples are formed from the distal end of a length of wire. The distal end of the wire is passed through a subject, and thereafter contacts a die that causes the wire to bend, thereby forming the staple. The wire is sufficiently firm to take the set imposed by the die. The staple portion is then cut from the wire by a knife. Again, such a system suffers from the fact that it does not permit sufficient flexibility in all situations with regard to the appropriate tension to be applied to the subject, since the attachment is made by a staple which has a predefined geometry and is formed with relatively firm wire. In addition, the system is limited as to the type of fastening which may be applied, since the surgical instrument is limited to only applying wire staples.
There is a need, therefore, for a new suturing device that permits minimally disruptive suturing and permits flexibility in the placement, application, and tensioning of the suture material.
The invention provides a device for introducing a flexible elongated element through a subject.
In one form of the invention, the device includes a tool for joining a first layer of material to a second layer of material, the tool comprising a handle, a first jaw and a second jaw mounted on the handle, at least one of the first jaw and the second jaw being moveable relative to the other; the first jaw defining therein: a first channel for retaining a wire guide; a second channel extending from the first channel for supporting a suture wire extending from the wire guide; and a passageway for retaining a cutting bar; the second channel being curved to impart a looping configuration to portions of the suture wire passed therethrough; a wire advancing actuator mounted on the handle for moving the suture wire through the second channel and through the first and second layers of material in the looping configuration; and a wire cutting actuator mounted on the handle for moving the cutting bar into cutting engagement with the suture wire, wherein the suture wire in the looping configuration joins the first layer of material to the second layer of material.
In another form of the invention, there is provided a method for joining a first layer of material and a second layer of material, the method comprising:
providing a tool for joining a first layer of material to a second layer of material, the tool comprising:
a handle;
a first jaw and a second jaw mounted on the handle, at least one of the first jaw and the second jaw being moveable relative to the other;
the first jaw defining therein:
a first channel for retaining a wire guide;
second channel extending from the first channel for supporting a suture wire extending from the wire guide; and
a passageway for retaining a cutting bar;
the second channel being curved to impart a looping configuration to portions of the suture wire passed therethrough;
a wire advancing actuator mounted on the handle for moving the suture wire through the second channel and through the first and second layers of material in the looping configuration; and
a wire cutting actuator mounted bn the handle for moving the cutting bar into cutting engagement with the suture wire, wherein the suture wire in the looping configuration joins the first layer of material to the second layer of material;
placing the first layer of material and the second layer of material between the first jaw and the second jaw;
advancing the suture wire out of the first jaw to form the looping configuration of the suture wire through the first layer of material and the second layer of material between the first jaw and the second jaw so as to join the first layer and the second layer to one another;
advancing the cutting bar through the suture wire so as to sever the looping configuration of the suture wire and a remaining portion of the suture wire in the second channel from one another.